Thursday, November 21 2024

D 02 - Processes for your operational management system - Set of documents

Document set - 108 process sheets for your operational management system

 
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D 02 - Processes for your operational management system - Set of documents
  • Added the: 07/05/2008
  • Last update: 19/04/2024
  • Number of pages: 226
See other documents

See the set of documents D 15v15 ISO 9001 Readiness

See the set of documents D 35v15 ISO 9001 Internal audit

See the set of documents D 65v15 ISO 9001 package
 

You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.

Description

All these documents can be modified to adapt to your needs and your context.

See also document set D 48 Quality manager function

See also document set D 52 QSE manager function

Documents present in the packages:

 

D 02 Process sheets for your management system
Codification Title Sub-clause Pages
  Management    
PQBD02M1 Develop strategy (example in pdf) 5.1.1 2
PQBD02M2 Satisfy requirements 4.2 2
PQBD02M3 Identify hazards and assess OH&S risks ***6.1.1 2
PQBD02M4 Establish process ownership 4.4 2
PQBD02M5 Establish policy 5.2 2
PQBD02M6 Address risks  6.1 2
PQBD02M7 Identify environmental aspects and impacts *6.1.2 2
PQBD02M8 Implement preventive actions **6.1.2.2 2
PQBD02M9 Plan the QMS (quality management system)   6.2 2
PQBD02M10 Deploy objectives  *6.2.1 2
PQBD02M11 Acquire resources  7.1 2
PQBD02M12 Communicate  7.4; **8.5.5.1 2
PQBD02M13 Negotiate the contract   8.2.1 2
PQBD02M14 Conduct second-party audit **8.4.2.4.1 2
PQBD02M15 Measure the satisfaction 9.1.2 2
PQBD02M16 Analyse data 9.1.3 2
PQBD02M17 Audit 9.2 2
PQBD02M18 Carry out management review  9.3 2
PQBD02M19 Improve  10.3; **10.3.1 2
PQBD02M20 Consult workers ***5.4 2
PQBD02M21 Evaluate compliance ***9.1.2 2
PQBD02M22 Assess risks ¤¤¤6.1.2 2
PQBD02M23 Treat risks ¤¤¤6.1.3 2
PQBD02M24 Delegate decision-making ¤¤¤¤5.3 2
  Realization    
PQBD02R1 Guarantee product safety (example in pdf) **4.4.1.2; ****8.1.3 2
PQBD02R2 Investigate incident  ***10.2 2
PQBD02R3 Elaborate contingency plans **6.1.2.3 2
PQBD02R4 Maintain equipment   7.1 2
PQBD02R5 Recall equipment  ****7.1.5.2 2
PQBD02R6 Manage calibration/verification records **7.1.5.2.1 2
PQBD02R7 Carry out FMEA  8.3; **7.3.1.1 2
PQBD02R8 Sterilize medical devices   ¤¤7.5 2
PQBD02R9 Carry out process review   8.1 2
PQBD02R10 Manage waste  *8.1 2
PQBD02R11 Transfer of work ****8.1 2
PQBD02R12 Manage critical items   ****8.1 f 2
PQBD02R13 Manage operational risk  ****8.1.1 2
PQBD02R14 Struggle against counterfeit parts ****8.1.4 2
PQBD02R15 Prevent emergency situations  *8.2 2
PQBD02R16 Implement PRPs  ¤8.2 2
PQBD02R17 Notify regulatory authorities   ¤¤8.2 2
PQBD02R18 Design and development   8.3 2
PQBD02R19 Notify customers on changes  ****8.3.6 2
PQBD02R20 Assess embedded software **8.3.2.3 2
PQBD02R21 Manage special characteristics **8.3.3.3 2
PQBD02R22 Approve product   **8.3.4.4 2
PQBD02R23 Purchase components 8.4 2
PQBD02R24 Control outsourced processes  8.4 2
PQBD02R25 Manage external providers  ****8.4.1.1 2
PQBD02R26 Evaluate test reports ****8.4.2 2
PQBD02R27 Meet statutory and regulatory requirements **8.4.2.2 2
PQBD02R28 Produce  8.5 2
PQBD02R29 Establish the HACCP plan  ¤8.5 2
PQBD02R30 Receive, store and deliver  8.5.1 2
PQBD02R31 Implement control plan   **8.5.1.1 2
PQBD02R32 Inspect first article ****8.5.1.3 2
PQBD02R33 Implement traceability  8.5.2; **8.5.2.1 2
PQBD02R34 Manage changes 8.5.6; **8.5.6.1 2
PQBD02R35 Use alternate methods ****8.5.6.1.1 2
PQBD02R36 Sell products  8.6 2
PQBD02R37 Approve rework and repair **8.7.1.4; **8.7.1.5 2
PQBD02R38 Dispose of nonconforming products **8.7.1.7 2
PQBD02R39 Inspect production 9.1 2
PQBD02R40 Control nonconformities 10.2 2
PQBD02R41 Implement corrective actions  10.2 2
PQBD02R42 Solve problems **10.2.3 2
PQBD02R43 Use error-proofing devices **10.2.4 2
PQBD02R44 Meet security requirements ¤¤¤8.1 2
PQBD02R45 Register and unsubscribe ¤¤¤8.1 2
PQBD02R46 Distribute access ¤¤¤8.1 2
PQBD02R47 Manage authentication ¤¤¤8.1 2
PQBD02R48 Develop and support security ¤¤¤8.1 2
PQBD02R49 Manage security continuity ¤¤¤8.1 2
PQBD02R50 Implement security ¤¤¤8.1 2
PQBD02R51 Manage networks ¤¤¤8.1 2
PQBD02R52 Monitor after marketing ¤¤8.2 2
PQBD02R53 Evaluate benefit/risk ratio ¤¤8.2 2
PQBD02R54 Manage operational requirements ¤¤¤¤8.1 2
PQBD02R55 Manage assets ¤¤¤A.5.9 2
PQBD02R56 Manage identities ¤¤¤A.5.16 2
PQBD02R57 Manage supplier security ¤¤¤A.5.19 2
PQBD02R58 Manage ICT supply chain ¤¤¤A.5.21 2
PQBD02R59 Manage cloud services ¤¤¤A.5.23 2
PQBD02R60 Manage incidents ¤¤¤A.5.24 2
PQBD02R61 Manage technical vulnerabilities ¤¤¤A.8.8 2
PQBD02R62 Manage configuration ¤¤¤A.8.9 2
PQBD02R63 Delete information ¤¤¤A.8.10 2
PQBD02R64 Use cryptography ¤¤¤A.8.24 2
PQBD02R65 Review information security ¤¤¤A.5.35 2
PQBD02R66 Test ¤¤¤A.8.29 2
PQBD02R67 Analyze business impact ¤¤¤¤¤8.2.2 2
PQBD02R68 Recover activities ¤¤¤¤¤8.4.5 2
PQBD02R69 Release of products and services 8.6 2
  Support    
PQBD02S1 Maintain regulatory watch (example in pdf) *6.1.3 2
PQBD02S2 Manage staff   7.1.2 2
PQBD02S3 Acquire and maintain infrastructure 7.1.3 2
PQBD02S4 Manage inspection means   7.1.5 2
PQBD02S5 Manage laboratory **7.1.5.3 2
PQBD02S6 Provide training  7.2 2
PQBD02S7 Verify auditor competency **7.2.3; **7.2.4 2
PQBD02S8 Empower employees **7.3.2 2
PQBD02S9 Provide information  7.5 2
PQBD02S10 Control documentation 7.5.3 2
PQBD02S11 Keep accountability  7.5.3 2
PQBD02S12 Manage configuration ****8.1.2 2
PQBD02S13 Manage IT 7.1.3 2
PQBD02S14 Apply discipline ¤¤¤A.6.4 2
PQBD02S15 Manage the employment contract ¤¤¤A.6.1 2
PQBD02A01 Processes and ISO 9001 sub-clauses   1
PQBD02A02 Process map  4.4 1
PQBD02A03 Processes and sub-clauses other standards   2
PQBD02List List of processes   3
Total   226

* ISO 14001; ** IATF 16949; *** ISO 45001; ****AS9100D; ¤ISO 22000; ¤¤ISO 13485; ¤¤¤ISO 27001; ¤¤¤¤ISO 37001; ¤¤¤¤¤ISO22301

M: management process

R: realization process

S: support process